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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bronchoscope (Flexible Or Rigid)
510(k) Number K254026
Device Name 3.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U); 6.0mm Large ProVu Video Bronchoscope (090-02-0060U); ProVu Video Bronchoscope 8 display (040-07-0082U)
Applicant
Flexicare Medical Limited.
Cynon Valley Business Park Mountain Ash
Rhondda Cynon Taf,  GB CF45 4ER
Applicant Contact Rebecca Funston
Correspondent
Flexicare Medical Limited.
Cynon Valley Business Park Mountain Ash
Rhondda Cynon Taf,  GB CF45 4ER
Correspondent Contact Kris Coles
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received12/16/2025
Decision Date 09/02/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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